Heart valve prostheses having multiple support arms and methods for percutaneous heart valve replacement

ABSTRACT

Prosthetic heart valve devices and associated methods for percutaneous or transcatheter heart valve replacement are disclosed herein. A heart valve prosthesis configured in accordance herewith includes a frame having a valve support and a plurality of support arms extending therefrom. The plurality of support arms may include a main support arm configured to extend from the valve support for capturing at least a portion of a valve leaflet of a native heart valve therebetween when the valve prosthesis is in an expanded configuration and deployed within the native heart valve. In addition, the plurality of support arms may include multiple supplemental support arms disposed about the circumference of the valve support that when deployed in the expanded configuration are configured to at least partially engage subannular tissue at the native heart valve.

FIELD OF THE INVENTION

The present technology relates generally to heart valve prostheses andassociated methods. In particular, several embodiments are directed totranscatheter heart valve devices having multiple support arms forpercutaneous replacement of native heart valves, such as a mitral valve.

BACKGROUND OF THE INVENTION

The human heart is a four chambered, muscular organ that provides bloodcirculation through the body during a cardiac cycle. The four mainchambers include the right atria and right ventricle which supplies thepulmonary circulation, and the left atria and left ventricle whichsupplies oxygenated blood received from the lungs to the remaining body.To insure that blood flows in one direction through the heart,atrioventricular valves (tricuspid and mitral valves) are presentbetween the junctions of the atria and the ventricles, and semi-lunarvalves (pulmonary valve and aortic valve) govern the exits of theventricles leading to the lungs and the rest of the body. These valvescontain leaflets that open and shut in response to blood pressurechanges caused by the contraction and relaxation of the heart chambers.The leaflets move apart from each other to open and allow blood to flowdownstream of the valve, and coapt to close and prevent backflow orregurgitation in an upstream manner.

Diseases associated with heart valves, such as those caused by damage ora defect, can include stenosis and valvular insufficiency orregurgitation. For example, valvular stenosis causes the valve to becomenarrowed and hardened which can prevent blood flow to a downstream heartchamber to occur at the proper flow rate and cause the heart to workharder to pump the blood through the diseased valve. Valvularinsufficiency or regurgitation occurs when the valve does not closecompletely, allowing blood to flow backwards, thereby causing the heartto be less efficient. A diseased or damaged valve, which can becongenital, age-related, drug-induced, or in some instances, caused byinfection, can result in an enlarged, thickened heart that loseselasticity and efficiency. Some symptoms of heart valve diseases caninclude weakness, shortness of breath, dizziness, fainting,palpitations, anemia and edema, and blood clots which can increase thelikelihood of stroke or pulmonary embolism. Symptoms can often be severeenough to be debilitating and/or life threatening.

Prosthetic heart valves have been developed for repair and replacementof diseased and/or damaged heart valves. Such valves can bepercutaneously delivered and deployed at the site of the diseased heartvalve through catheter-based systems. Such prosthetic heart valves canbe delivered while in a low-profile or compressed/contracted arrangementso that the prosthetic valves can be contained within a sheath componentof a delivery catheter and advanced through the patient's vasculature.Once positioned at the treatment site, the prosthetic valves can beexpanded to engage tissue at the diseased heart valve region to, forinstance, hold the prosthetic valve in position. While these prostheticvalves offer minimally invasive methods for heart valve repair and/orreplacement, challenges remain to provide prosthetic valves that preventleakage between the implanted prosthetic valve and the surroundingtissue (paravalvular leakage) and for preventing movement and/ormigration of the prosthetic valve that could occur during the cardiaccycle. For example, the mitral valve presents numerous challenges, suchas prosthetic valve dislodgement or improper placement due to thepresence of chordae tendinae and remnant leaflets, leading to valveimpingement. Additional challenges can include providing a prostheticvalve that resists pre-mature failure of various components that canoccur when subjected to the distorting forces imparted by the nativeanatomy and during the cardiac cycle. Further anatomical challengesassociated with treatment of a mitral valve include providing aprosthetic valve to accommodate the kidney shape of the annulus.Moreover, the annulus has muscle only along the exterior wall of thevalve with only a thin vessel wall that separates the mitral valve andthe aortic valve. This anatomical muscle distribution, along with thehigh pressures experienced on the left ventricular contraction, can beproblematic for mitral valve prosthesis.

BRIEF SUMMARY OF THE INVENTION

Embodiments hereof are directed to heart valve prostheses havingmultiple support arms and methods of percutaneous implantation thereof.The heart valve prosthesis has a compressed delivery configuration andan expanded deployed configuration for deployment within a native heartvalve or a prior implanted prosthetic heart valve. The valve prosthesisincludes a frame having a tubular portion for retaining a prostheticvalve component therein, the tubular portion having a first end and asecond end. An inflow portion of the frame radially extends from thefirst end of the tubular or conical portion when the valve prosthesis isin the expanded configuration. A main support arm of the frame extendsfrom the second end of the tubular portion and has a first length. Afirst set of supplemental support arms of the frame also extend from thesecond end of the tubular portion and each of the first set ofsupplemental support arms has a second length. A second set ofsupplemental support arms of the frame also extend from the second endof the tubular portion and each of the second set of supplementalsupport arms has a third length that is less than the second length. Inembodiment hereof, a first length of the main support arm is longer thanthe respective second and third lengths of the supplemental support armsin the first and second sets of supplemental support arms.

In another embodiment, a heart valve prosthesis has a compresseddelivery configuration and an expanded deployed configuration fordeployment within a heart. The valve prosthesis has a frame that definesa valve support having a first end and a second end, and that defines aninflow portion that radially extends from the first end of the valvesupport when the valve prosthesis is in the expanded configuration. Theframe further defines and/or includes a main support arm extending fromthe second end of the valve support, a plurality of tall supplementalsupport arms extending from the second end of the valve support, and aplurality of short supplemental support arms extending from the secondend of the valve support, wherein the main support arm is longer thanthe pluralities of tall and short supplemental support arms. Inembodiments hereof, when the valve prosthesis is in the expandedconfiguration the main support arm, the plurality of tall supplementalsupport arms and the plurality of short supplemental support arms bendtoward the first end of the valve support, and each of the plurality oftall supplemental support arms and each of the plurality of shortsupplemental support arms has substantially the same deployed height.

Further aspects of the present technology are directed to methods ofdeploying a valve prosthesis having a compressed configuration fordelivery to a treatment site and an expanded configuration fordeployment within a heart. In one embodiment, a method can includeproviding transatrial access to a left atrium of the heart and advancinga distal portion of a delivery catheter having the valve prosthesis inthe compressed configuration therein into the left atrium via thetransatrial access. The valve prosthesis can include a frame having amain support arm and a plurality of supplemental support arms. Themethod can also include deploying within the left atrium the mainsupport arm and the plurality of supplemental support arms of the valveprosthesis such that each of the main support arm and the plurality ofsupplemental support arms assumes a bent deployed state as it extendsfrom the distal portion of the delivery catheter. The method can furtherinclude advancing the distal portion of the delivery catheter toward anannulus of a native mitral valve of the heart until the main support armand the plurality of supplemental support arms in the bent deployedstate are pushed through the annulus and into a left ventricle of theheart. The method can still further include proximally retracting orpulling the delivery catheter until each of the main support arm and theplurality of supplemental support arms engages at least a portion ofanterior, posterior leaflets, and/or the native annulus of the nativemitral valve, and deploying a remainder of the valve prosthesis from thedelivery catheter to replace the native mitral valve.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and aspects of the present technologycan be better understood from the following description of embodimentsand as illustrated in the accompanying drawings. The accompanyingdrawings, which are incorporated herein and form a part of thespecification, further serve to illustrate the principles of the presenttechnology. The components in the drawings are not necessarily to scale.

FIG. 1 is a schematic sectional illustration of a mammalian heart havingnative valve structures.

FIG. 2A is a schematic sectional illustration of a left ventricle of amammalian heart showing anatomical structures and a native mitral valve.

FIG. 2B is a schematic sectional illustration of the left ventricle ofthe heart having a prolapsed mitral valve in which the leaflets do notsufficiently coapt and which is suitable for replacement with variousembodiments of prosthetic heart valves in accordance with the presenttechnology.

FIG. 3A is a schematic illustration of a superior view a mitral valveisolated from the surrounding heart structures and showing the annulusand native leaflets.

FIG. 3B is a schematic illustration of a superior view a mitral valve,aortic mitral curtain and portions of the aortic valve isolated from thesurrounding heart structures and showing regions of the native mitralvalve leaflets.

FIG. 4A is a side view of a heart valve prosthesis in a deployed orexpanded configuration (e.g., a deployed state) in accordance with anembodiment of the present technology.

FIG. 4B is a perspective view of a frame of the heart valve prosthesisof FIG. 4A in the expanded configuration in accordance with anembodiment of the present technology.

FIG. 4C is a top view of the heart valve prosthesis of FIG. 4A in theexpanded configuration in accordance with an embodiment of the presenttechnology.

FIG. 4D is a bottom view of the heart valve prosthesis of FIGS. 4A and4B in the expanded configuration and in accordance with an embodiment ofthe present technology.

FIG. 5 is a schematic illustration showing a bottom or inferior view ofa native mitral valve in the heart viewed from the left ventricle andshowing the heart valve prosthesis of FIGS. 4A-4D implanted at thenative mitral valve in accordance with an embodiment of the presenttechnology.

FIG. 6 illustrates a cut-away view of a heart showing a partial sideview of a heart valve prosthesis implanted at a native mitral valve inaccordance with an embodiment of the present technology.

FIG. 7 shows a cut pattern for a frame of the heart valve prosthesis ofFIG. 4A in accordance with an embodiment of the present technology.

FIGS. 8A-8C are enlarged partial side views of a heart valve prosthesishaving a main (FIG. 8A) or various supplemental (FIGS. 8B and 8C)support arms coupled to and extending from a valve support at variousangles with respect to a longitudinal axis of the valve support inaccordance with further embodiments of the present technology.

FIG. 9 is an enlarged sectional view of the heart valve prosthesis ofFIGS. 4A-4D shown in a delivery configuration (e.g., low-profile orradially compressed state) in accordance with an embodiment of thepresent technology.

FIGS. 10A-10D are sectional views of the heart illustrating steps of amethod of implanting a heart valve prosthesis using an antegrade ortransseptal approach in accordance with another embodiment of thepresent technology.

FIG. 11 is flow diagram illustrating a method for repairing or replacinga heart valve of a patient in accordance with an embodiment of thepresent technology.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present technology are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. The terms “distal” and“proximal” are used in the following description with respect to aposition or direction relative to the treating clinician or with respectto a prosthetic heart valve device. For example, “distal” or “distally”are a position distant from or in a direction away from the clinicianwhen referring to delivery procedures or along a vasculature. Likewise,“proximal” and “proximally” are a position near or in a direction towardthe clinician. With respect to a prosthetic heart valve device, theterms “proximal” and “distal” can refer to the location of portions ofthe device with respect to the direction of blood flow. For example,“proximal” can refer to an upstream position or a position of bloodinflow, and “distal” can refer to a downstream position or a position ofblood outflow.

The following detailed description is merely exemplary in nature and isnot intended to limit the present technology or the application and usesof the present technology. Although the description of embodimentshereof are in the context of treatment of heart valves and particularlya mitral valve, the present technology may also be used in any otherbody passageways where it is deemed useful. Furthermore, there is nointention to be bound by any expressed or implied theory presented inthe preceding technical field, background, brief summary or thefollowing detailed description.

Embodiments of the present technology as described herein can becombined in many ways to treat one or more of many valves of the bodyincluding valves of the heart such as the mitral or tricuspid valve. Theembodiments of the present technology can be therapeutically combinedwith many known surgeries and procedures, for example, such embodimentscan be combined with known methods of accessing the valves of the heartsuch as the mitral valve with antegrade approaches, such as atransseptal or transatrial approach, and combinations thereof.

FIG. 1 is a schematic sectional illustration of a mammalian heart 10that depicts the four heart chambers (right atria RA, right ventricleRV, left atria LA, left ventricle LV) and native valve structures(tricuspid valve TV, mitral valve MV, pulmonary valve PV, aortic valveAV). FIG. 2A is a schematic sectional illustration of a left ventricleLV of a mammalian heart 10 showing anatomical structures and a nativemitral valve MV. Referring to FIGS. 1 and 2A together, the heart 10comprises the left atrium LA that receives oxygenated blood from thelungs via the pulmonary veins. The left atrium LA pumps the oxygenatedblood through the mitral valve MV and into the left ventricle LV duringventricular diastole. The left ventricle LV contracts during systole andblood flows outwardly through the aortic valve AV, into the aorta and tothe remainder of the body.

In a healthy heart, the leaflets LF of the mitral valve MV meet evenlyat the free edges or “coapt” to close and prevent back flow of bloodduring contraction of the left ventricle LV (FIG. 2A). Referring to FIG.2A, the leaflets LF attach the surrounding heart structure via a densefibrous ring of connective tissue called an annulus AN which is distinctfrom both the leaflet tissue LF as well as the adjoining muscular tissueof the heart wall. In general, the connective tissue at the annulus ANis more fibrous, tougher and stronger than leaflet tissue. The flexibleleaflet tissue of the mitral leaflets LF are connected to papillarymuscles PM, which extend upwardly from the lower wall of the leftventricle LV and the interventricular septum IVS, via branching tendonscalled chordae tendinae CT. In a heart 10 having a prolapsed mitralvalve MV in which the leaflets LF do not sufficiently coapt or meet, asshown in FIG. 2B, leakage from the left atrium LA into the leftventricle LV will occur. Several structural defects can cause the mitralleaflets LF to prolapse such that regurgitation occurs, includingruptured chordae tendinae CT, impairment of papillary muscles PM (e.g.,due to ischemic heart disease), and enlargement of the heart and/ormitral valve annulus AN (e.g., cardiomyopathy).

FIG. 3 is a superior view of a mitral valve MV isolated from thesurrounding heart structures and further illustrating the shape andrelative sizes of the mitral valve leaflets AL, PL and annulus AN. FIG.3B is a schematic illustration of a superior view a mitral valve MV,aortic mitral curtain and portions of the aortic valve AV isolated fromthe surrounding heart structures and showing regions of the nativemitral valve leaflets AL, PL. With reference to FIGS. 3A and 3Btogether, the mitral valve MV includes an anterior leaflet AL withsegments or scallops A1, A2, and A3 that meet and oppose respectivesegments or scallops P1, P2 and P3 of a posterior leaflet PL at acoaptation line C (FIG. 3B) when closed. FIGS. 3A and 3B togetherfurther illustrate the shape and relative sizes of the leaflets AL, PLof the mitral valve. As shown, the mitral valve MV generally has a “D”or kidney-like shape and the line of coaptation C is curved or C-shaped,thereby defining a relatively large anterior leaflet AL andsubstantially smaller posterior leaflet PL. Both leaflets appeargenerally crescent-shaped from the superior or atrial side, with theanterior leaflet AL being substantially wider in the middle of the valveat the A2 segment thereof than the posterior leaflet at the P2 segmentthereof (e.g., comparing segments A2 and P2, FIG. 3B). As illustrated inFIGS. 3A and 3B, at the opposing ends of the line of coaptation C, theleaflets join together at corners called the anterolateral commissure ACand posteromedial commissure PC, respectively. When the anterior leafletAL and posterior leaflet PL fail to meet (FIG. 3A), regurgitationbetween the leaflets AL, PL or at commissures AC, PC at the cornersbetween the leaflets can occur.

Referring to FIGS. 3A and 3B, the mitral valve annulus AN is a fibroticring that consists of an anterior part and a posterior part. Theaortic-mitral curtain (FIG. 3B) is a fibrous structure that connects theanterior mitral annulus AN intimately with the aortic valve annulus (atthe level of the left and non-coronary cusps or sinuses). The posteriorpart of the mitral annulus AN is not reinforced by other structures ofthe heart and is rather discontinuous (making it prone to dilatation).The leaflets AL, PL and the annulus AN are comprised of different typesof cardiac tissue having varying strength, toughness, fibrosity, andflexibility. Furthermore, the mitral valve MV may also comprise a regionof tissue interconnecting each leaflet to the annulus AN (indicated atdashed line in FIG. 3A).

A person of ordinary skill in the art will recognize that the dimensionsand physiology of the patient may vary among patients, and although somepatients may comprise differing physiology, the teachings as describedherein can be adapted for use by many patients having variousconditions, dimensions and shapes of the mitral valve. For example, workin relation to embodiments suggests that patients may have a longdimension across the annulus and a short dimension across the annuluswith or without well-defined peak and valley portions, and the methodsand device as described herein can be configured accordingly.

Embodiments of prosthetic heart valve devices and associated methods inaccordance with the present technology are described in this sectionwith reference to FIGS. 4A-11. It will be appreciated that specificelements, substructures, uses, advantages, and/or other aspects of theembodiments described herein and with reference to FIGS. 4A-11 can besuitably interchanged, substituted or otherwise configured with oneanother in accordance with additional embodiments of the presenttechnology.

Provided herein are systems, devices and methods suitable forpercutaneous delivery and implantation of prosthetic heart valves in aheart of a patient, wherein the prosthetic heart valves may be referenceto as a transcatheter valve prosthesis. In some embodiments, methods anddevices are presented for the treatment of valve disease by minimallyinvasive implantation of artificial or prosthetic heart valves. Forexample, a prosthetic heart valve device, in accordance with embodimentsdescribed herein, can be implanted for replacement of a diseased ordamaged native mitral valve or prior implanted prosthetic mitral valvein a patient, such as in a patient suffering from a prolapsed mitralvalve illustrated in FIG. 2A. In further embodiments, the device issuitable for implantation and replacement of other diseased or damagedheart valves or prior implanted prosthetic heart valves, such astricuspid, pulmonary and aortic heart valves. A transcatheter valveprosthesis in accordance with embodiments hereof has a compressedconfiguration for delivery via a delivery catheter within a vasculatureand an expanded configuration for deployment within a heart.

FIG. 4A is a side view of a heart valve prosthesis or a prosthetic heartvalve device 100 in a radially expanded configuration (e.g., a deployedstate) in accordance with an embodiment of the present technology. FIG.4B is a perspective view of a frame or stent-like support structure 110of the heart valve prosthesis 100 of FIG. 4A in the expandedconfiguration in accordance with an embodiment of the presenttechnology. FIGS. 4C and 4D are top or superior side and bottom orinferior side views, respectively, of the heart valve prosthesis 100 ofFIG. 4A in the expanded configuration in accordance with an embodimentof the present technology. Referring to FIGS. 4A-4D together, the heartvalve prosthesis 100 has the frame or stent-like support structure 110that includes a tubular portion or structural valve support 120 thatdefines a lumen 121 for retaining, holding and/or securing a prostheticvalve component 130 (FIGS. 4C and 4D) therein. The valve support 120 canbe generally cylindrical in shape having an upstream or a first end 125and a downstream or a second end 127 with respect to a longitudinal axisL_(A) of the valve support 120 (FIG. 4A). The frame 110 further includesa plurality of support arms extending radially outward from the valvesupport 120 and generally in an upstream direction from the downstreamend 127 of the valve support 120 (e.g., to reach behind native leafletsof the mitral valve and/or engage cardiac tissue in the subannularregion within the left ventricle). In particular, the plurality ofsupport arms can include a main support arm 142 and a plurality ormultiple supplemental support arms 144 having variable characteristics(e.g., lengths, widths, reflection angles from the valve support 120,shapes, etc.) configured to engage the leaflets and/or annular cardiactissue in a manner that distributes loads associated with forces exertedon the heart valve prosthesis 100 during the cardiac cycle and in amanner that inhibits migration of the prosthesis 100. In this way, theplurality of support arms provides the benefits of preventingparavalvular leakage between the prosthesis 100 and the native tissue aswell as preventing damage to the native tissue.

At least one of the support arms is a main support arm 142 sized andpositioned to extend from a perimeter of the valve support 120 such thatmain support arm 142 is configured and oriented to engage the middlesegment A2 of the anterior leaflet AL (FIG. 3B) of the mitral valve MVwithout substantially obstructing the left ventricular outflow tract(LVOT, FIG. 1). As shown in FIGS. 4A-4D, the heart valve prosthesis 100further incorporates a plurality of supplemental support arms 144 arounda circumference of the valve support 120 of the heart valve prosthesis100, and in some embodiments, the prosthesis 100 may include theplurality of supplemental support arms 144 in sets or groupings, e.g.,first and second sets or groupings so as to engage the anterior andposterior leaflets, respectively. Additionally, the supplemental supportarms 144 may extend from the valve support 120 independently of othercomponents including the main support arm 142 and/or other supplementalsupport arms 144, such as shown in FIGS. 4A, 4B and 4D.

As shown in FIG. 4D, the supplemental support arms 144 of the heartvalve prosthesis 100 include a first set of supplemental support arms146 (individually referred to as 146 a, 146 b, 146 c and 146 d)distributed on either side of the main support arm 142 and on ananterior side of the heart valve prosthesis 100 so as to be configuredto be aligned with the anterior leaflet AL (FIG. 3B). The supplementalsupport arms 144 of the heart valve prosthesis 100 further include asecond set of supplemental support arms 148 (individually referred to as148 a, 148 b and 148 c) distributed about or on a posterior side of theheart valve prosthesis 100 so as to be configured to be aligned with theposterior leaflet PL (FIG. 3B). The first and second sets ofsupplemental support arms 146, 148 are configured to at least partiallyengage subannular tissue such that the heart valve prosthesis 100 issupported by the annulus AN when the prosthetic valve component 130 isclosed during systole. In accordance with embodiments hereof, each ofsupplemental support arms 146 a-146 d may be referred to as a tall ortaller supplemental support arm and each of supplemental support arms148 a-148 c may be referred to as a short or shorter supplementalsupport arm, with “tall” or “taller” and “short” or “shorter” referringto the length of the supplemental support arms 146 a-146 d relative tothe length of the supplemental support arms 148 a-148 c. As well itshould be understood that when either of the terms supplemental supportarm 144 or supplemental support arms 144 is used herein (or in thefigures) that the term is intended to refer to a supplemental supportarm or supplemental support arms of one or both of the first and secondsets of supplemental support arms 146 and 148.

FIG. 5 is a schematic illustration showing a bottom or inferior view ofa native mitral valve MV in the heart 10 viewed from the left ventricleLV and showing the heart valve prosthesis 100 of FIGS. 4A-4D implantedat the native mitral valve MV in accordance with an embodiment of thepresent technology. As shown in this illustration, the main support arm142 is oriented to receive and capture the anterior leaflet AL at the A2segment proximate to the aortic-mitral curtain and the left andnon-coronary cusps (FIG. 3B). The supplemental support arms 144 extendaround the anterior leaflet AL and/or posterior leaflet PL (not shown)and between chordae tendinae CT of the mitral valve MV when theprosthesis is implanted. As best seen in FIG. 5, the main support arm142 on the anterior-oriented side of the prosthesis 100 can beconfigured to extend through a gap in the chordae tendinae CT near thecenter of the native anterior leaflet AL, while the supplemental supportarms 144 are sized to extend through the chordae tendinae CT, behind therespective leaflets AL, PL and to the annulus.

In some embodiments, and as shown in the radially expanded configurationof FIGS. 4A and 4B, the frame 110 further includes an inflow portion150, such as radially-extending segment 150 at least partiallysurrounding and extending from the upstream end 125 of the valve support120. The radially-extending segment 150 can include a plurality ofself-expanding struts 152 configured to radially expand when the heartvalve prosthesis 100 is deployed to the expanded configuration. In somearrangements, the radially-extending segment 150 can engage tissue on orabove the annulus when implanted within a native mitral valve space. Inthis embodiment, the radially-extending segment 150 can retain the valvesupport 120 in a desired position within the native valve region (e.g.,between the native leaflets and annulus of the mitral valve). Referringto FIGS. 4A, 4C and 4D, the radially-extending segment 150, the valvesupport 120 and/or one or more portions of the plurality of support arms142, 144 can include a sealing material 160 to prevent leakage of blood(e.g., paravalvular leakage) between the implanted heart valveprosthesis 100 and the native heart tissue. For example, the sealingmaterial 160 can extend around an upper or upstream surface 154 or alower or downstream surface 155 (FIG. 4A) of the radially-extendingsegment 150, and/or around an interior wall or surface 122 or anexterior wall or surface 123 of the valve support 120 (shown in FIG.4C).

Referring to FIG. 4C, the radially-extending segment 150 and valvesupport 120 are shown having generally circular cross-sectional shapeswith the radially-extending segment 150 having a cross-sectionaldimension D₁ that is greater than a cross-sectional dimension D₂ of thevalve support 120. In some embodiments, the radially-extending segment150, the valve support 120 or both can have other cross-sectionalshapes, such as to accommodate the D-shaped or kidney-shaped mitralvalve. For example, the radially-extending segment 150 and/or valvesupport 120 may expand to an irregular, non-cylindrical, or oval-shapedconfiguration for accommodating the mitral valve or to correspond to ashape of another valve. Furthermore, the native valves (e.g., mitral,aortic) can be uniquely sized and/or have other unique anatomical shapesand features that vary between patients, and the prosthesis 100 forreplacing or repairing such valves can be suitable for adapting to thesize, geometry and other anatomical features of such native valves. Forexample, the radially-extending segment 150 can expand within the nativeheart valve region while simultaneously being flexible so as to conformto the region engaged by the radially-extending segment 150. In anembodiment, the radially-extending segment 150 may have a saddle shapepreset during the manufacturing processing to match the native annulusprofile.

FIGS. 4A-4C show the radially-extending segment 150 having the pluralityof struts 152 that outwardly extend from the exterior wall 123 at thefirst end 125 of the valve support 120. In one embodiment, the struts152 are arranged relatively evenly about a circumference of the valvesupport 120, and individual struts 152 join an adjacent strut 152 at acrown 156. In one embodiment the crowns 156 have an atraumatic tip 157that prevents injury to the cardiac tissue during deployment and throughthe cardiac cycle. Examples of suitable radially-extending segments 150are described in U.S. Patent Publication No. 2015/0119982, which isincorporated by reference herein in its entirety.

Referring to FIGS. 4C and 4D, the prosthetic valve component 130 may becoupled to the interior wall 122 of the valve support 120 for governingblood flow through the heart valve prosthesis 100. For example, theprosthetic valve component 130 can include a plurality of leaflets 132(shown individually as 132 a-c) that coapt and are configured to allowblood flow through the heart valve prosthesis 100 in a downstreamdirection (e.g., from the first or upstream end 125 to the second ordownstream end 127) and to inhibit blood flow in an upstream orretrograde direction (e.g., from the second end 127 to the first end125). While the prosthetic valve component 130 is shown having atricuspid arrangement, it is understood that the prosthetic valvecomponent 130 can have 2 leaflets 132 (bicuspid arrangement, not shown)or more than three leaflets 132 that coapt to close the prosthetic valvecomponent 130. In one embodiment, the leaflets 132 can be formed ofbovine pericardium or other natural material (e.g., obtained from heartvalves, aortic roots, aortic walls, aortic leaflets, pericardial tissue,such as pericardial patches, bypass grafts, blood vessels, intestinalsubmucosal tissue, umbilical tissue and the like from humans or animals)that are mounted to the interior wall 122 of the valve support 120. Inanother embodiment, synthetic materials suitable for use as valveleaflets 132 include DACRON® polyester (commercially available fromInvista North America S.A.R.L. of Wilmington, Del.), other clothmaterials, nylon blends, polymeric materials, and vacuum depositionnitinol fabricated materials. In yet a further embodiment, valveleaflets 132 can be made of an ultra-high molecular weight polyethylenematerial commercially available under the trade designation DYNEEMA fromRoyal DSM of the Netherlands. With certain leaflet materials, it may bedesirable to coat one or both sides of the leaflet with a material thatwill prevent or minimize overgrowth. It can be further desirable thatthe leaflet material is durable and not subject to stretching,deforming, or fatigue.

FIG. 6 illustrates a cut-away view of a heart 10 showing a partial sideview of the heart valve prosthesis 100 implanted at a native mitralvalve MV in accordance with an embodiment of the present technology. Theprosthesis 100 is shown in FIG. 6 having only a main support arm 142 andone diametrically opposed supplemental support arm 148 b for purposes ofillustration only. Generally, when implanted, the upstream end 125 ofthe valve support 120 is oriented to receive blood inflow from a firstheart chamber, e.g., left atrium LA for mitral valve MV replacement,left ventricle for aortic valve replacement, etc., and the downstreamend 127 is oriented to release blood outflow into a second heart chamberor structure, e.g., left ventricle LV for mitral valve MV replacement,aorta for aortic valve replacement.

Referring to FIGS. 4A, 4B, 4D, 5 and 6 together, the plurality ofsupport arms 142, 144 extend from the downstream end 127 of the valvesupport 120, and are spaced about the circumference of the exterior wall123 of the valve support 120 (FIG. 4D). As shown in FIG. 4D, the supportarms 142, 144 can be grouped closer together and/or farther apart andextend from the valve support 120 at positions that are configured togenerally align with the anterior and posterior leaflets of the mitralvalve when deployed. For example, the main support arm 142 is configuredto be generally aligned with the middle segment or scallop A2 of theanterior leaflet AL (FIGS. 3B and 5). The first set of supplementalsupport arms 146 flank the main support arm 142 such that they willinteract with the anterior leaflet AL at the A1 and A3 segmentsproximate the commissures. For example, supplemental support arms 146 aand 146 b of the first set of supplemental support arms 146 areconfigured to reach behind the anterior leaflet (e.g., interact with theventricle side or outward-facing surface) near the anterolateralcommissure AC, while the remaining supplemental support arms 146 c and146 d of the first set of supplemental support arms 146 are configuredto reach behind the anterior leaflet (e.g., interact with the ventricleside or outward-facing surface) near the posteromedial commissure PC.Likewise, as shown in FIG. 4D, the second set of supplemental supportarms 148 a, 148 b, 148 c are arranged about the remainder of thecircumference of the exterior wall 123 of the valve support 120 suchthat they will interact with the posterior leaflet PL at the P1, P2 andP3 segments, respectively. In this example, the supplemental support arm148 b of the second set of support arms 148 is diametrically opposed tothe main support arm 142. In other arrangements, however, another of thesecond set of supplemental support arms 148 (e.g., 148 a or 148 c) maybe oriented so as to be diametrically opposed with the main support arm142 and/or configured to interact with the P2 segment of the posteriorleaflet PL. In general, including in arrangements not shown, theplurality of support arms can be generally evenly spaced, unevenlyspaced, grouped, irregularly spaced, etc. about the circumference.

The embodiment shown in FIG. 4D has eight support arms spaced about thecircumference of the valve support 120, including one main support arm142 and seven supplemental support arms 144. Of the seven supplementalsupport arms 144, four are in the first set of supplemental support arms146 configured to extend behind portions of the anterior leaflet and/ornear the anterolateral and posteromedial commissures AC, PC.Additionally, three of the supplemental support arms 144 are in thesecond set of supplemental support arms 148 configured to extend behindportions of the posterior leaflet. In alternative arrangements, theprosthesis 100 can include more or less than 8 support arms and/or othercombinations of main support arms 142 and supplemental support arms 144,for example by way of illustration but not limitation, two main supportarms, two to six supplemental support arms, greater than sevensupplemental support arms, nine supplemental support arms, etc.

Referring to FIGS. 4A, 4B and 6 together, each of the plurality ofsupport arms may extend from the valve support 120 at or near thedownstream or second end 127 and may be described as extending generallytoward the upstream or first end 125 along or in parallel with theexterior wall 123 of the valve support 120. Stated another way each ofthe plurality of support arms may be considered to be flared away fromvalve support 120 to engage native commissures when the prosthesis isimplanted in the expanded or deployed state. When the prosthesis is inthe expanded or deployed state, as shown in FIG. 4A, the plurality ofsupport arms may be configured to longitudinally extend in an upstreamdirection to variable heights with respect to a height H₁ of the valvesupport 120. In the embodiment shown in FIG. 4A, a height or deployedheight H₂ of the deployed or expanded main support arm 142 is less thana height or deployed height H₃ of the deployed or expanded plurality ofsupplemental support arms 144. In other arrangements the height H₂ andthe height H₃ can be substantially the same. In embodiments hereof asdescribed in more detail below, when referring only to the supplementalsupport arms 144, although lengths are different for the first andsecond sets of supplemental support arms 146 and 148 when in thecrimped, straightened or delivery configuration, their heights, once inthe deployed configuration are configured to be the same. In embodimentshereof the deployed heights are substantially the same because thelonger arms (arms 146 a-146 d) are set out at a wider angle, andtherefore have less total height when deployed, as compared to theshorter arms (arms 148 a-148 c), which in an embodiment may deploynearly parallel to the valve housing, creating similar heights betweenthe sets. An objective of having all the supplemental arms (the longerand shorter ones) with the same height once deployed is that each willthen contact the ventricular side of the annulus, which is more or lessplanar. In embodiments hereof, the heights H₂, H₃ are measured relativeto the second end 127 of the valve support 120. The height H₂ achievedby the main support arm 142 (e.g., whether less than or equal to theheight H₃ of the supplemental support arms 144) is configured toprohibit the main support arm 142 from impinging upon the leaflets ofthe aortic valve AV (FIGS. 3B and 6). By avoiding the cardiac tissuealong the mid-anterior portion of the mitral valve MV annulus AN, themain support arm 142 can capture the anterior leaflet tissue withoutsubstantially occluding the LVOT from within the left ventricle LV (FIG.6).

In general, the first and second sets of supplemental support arms 146and 148 are configured to extend to substantially or essentially thedeployed height H₃ relative to the second end 127 of the valve support120 and each supplemental support arm terminates in a rounded, curved,or otherwise atraumatic tip or end portion 145. In an embodiment, thedeployed height H₃ disposes or positions each end portion 145 of thesupplemental support arms of the first and second sets of supplementalsupport arms 146, 148 at substantially the same longitudinal positionrelative to the longitudinal axis L_(A) of the valve support 120. Theend portions 145 are configured to atraumatically engage tissue at ornear the subannular tissue so as to inhibit tissue damage due topenetration, tissue erosion and/or to resist movement of the heart valveprosthesis 100 in an upstream direction during ventricular systole, asis described further herein. In the embodiment shown in FIGS. 4A and 4B,the height H₃ of the first and second sets of supplemental support arms146, 148 is also configured to allow the supplemental support arms toextend around and behind the respective leaflets AL, PL to engage thefibrous connective tissue of the subannular surface and/or proximatemuscular tissue associated with a wall of the left ventricle LV (see,e.g., supplemental support arm 148 b in FIG. 6). The deployed height H₃of the first and second sets of supplemental support arms 146, 148 issufficient to allow the respective end portions 145 to contact and actagainst (e.g., in opposition to) the radially-extending segment 150 whenin an expanded state. When positioned for use within a native mitralvalve MV, the heart valve prosthesis 100 is configured to be deployed ina manner that captures and subsequently pinches annular tissue betweenthe radially-extending segment 150 and the end portions 145 of thesupplemental support arms 144 (FIG. 6). In another embodiment, when inan expanded state an apex or apices 153 (e.g., lower surface) of strutsof the radially-extending segment 150 can be longitudinally separatedfrom the end portions 145 of the supplemental support arms 144 by a gap(not shown). When implanted, the gap can be sized to receive annulartissue therein.

In one embodiment, an apex or apices 153 of the struts 152 of inflowportion 150 oppose a respective upstream oriented end portion 145 of arespective supplemental support arm 144 in such a manner that providescompressive forces Fc₁ and F_(C2), which act upon the contacted tissueof the annulus therebetween when implanted (FIG. 4A). Accordingly, thecompressive forces Fc₁ and Fc₂ may be aligned and/or opposed to eachother such that annular tissue is captured between theradially-extending segment 150 and the supplemental support arms 144(first and second sets of supplemental support arms 146, 148)distributed about the perimeter of the valve support 120 (FIG. 6). Insome instances, a respective apex 153 and a corresponding or opposingend portion 145 meet (e.g., when struts 152 are circumferentially- andradially-aligned with the end portion 145 of the supplemental supportarms 144 such that the compressive forces Fc₁ and F_(C2) are directlyopposed to effectively pinch the annulus AN therebetween) or otherwiseoverlap (e.g., when struts 152 are off-set from the end portion 145 asshown in FIGS. 4A and 4B) when the prosthesis 100 is full expanded(e.g., unbiased) and no gap is provided. In such embodiments, annulartissue can be captured between the end portions 145 of the supplementalsupport arms 144 and the lower surface of the radially-extending segment150 in a manner that places bias on or deflects at least one of thesupplemental support arms 144 (e.g., in a downstream direction) and/orone or more struts 152 of the radially-extending segment 150 (e.g., inan upstream direction). In arrangements providing a gap or in thearrangements hereof where no gap is provided, load distribution betweenthe plurality of support arms 142, 144 disposed about the circumferencecan inhibit migration of the heart valve prosthesis 100 over time,minimize load on native leaflet tissue and/or chordae tendinae CT (e.g.,to prevent damage due to stretching and/or deformation over time),and/or provide a gasket-like sealing effect about the circumference ofthe prosthesis 100 against the annular tissue of the native mitral valveMV. In accordance therewith, the supplemental support arms 144 aresplayed circumferentially so that end portions 145 are spaced apartalong the native annulus so as to distribute the load across a widerarea of the native subannular surface.

In some embodiments described herein, and in order to transform orself-expand between an initial compressed configuration (e.g., in adelivery state, not shown) and the deployed configuration (FIGS. 4A-6),the frame 110 is formed from a resilient or shape memory material, suchas a nickel titanium alloy (e.g., nitinol), that has a mechanical memoryto return to the deployed or expanded configuration. In one embodiment,the frame 110 can be a unitary structure that defines theradially-extending segment 150 at the inflow portion of the prosthesis100, the valve support 120 and the plurality of support arms 142, 144,and the frame 110 so described may be made from stainless steel, apseudo-elastic metal such as nickel titanium alloy or nitinol, or aso-called super alloy, which may have a base metal of nickel, cobalt,chromium, or other metal. In one embodiment, and as shown in FIG. 7, theframe 110 can be formed as a unitary structure, for e.g., from a lasercut, fenestrated, nitinol or other metal tube. Mechanical memory may beimparted to the structure that forms the frame 110 by thermal treatmentto achieve a spring temper in the stainless steel, for example, or toset a shape memory in a susceptible metal alloy, such as nitinol. Theframe 110 may also include polymers or combinations of metals, polymersor other materials. In one embodiment, the valve support 120 can be aballoon-expandable tubular metal stent, and the radially-extendingsegment 150 and the support arms 142, 144 of the frame 110 may be formedfrom material and by methods so as to be self-expanding as describedabove.

FIG. 7 shows a cut pattern for a frame 110 of the heart valve prosthesis100 of FIG. 4A in accordance with an embodiment of the presenttechnology. As illustrated in FIG. 7, the frame 110 can include aunitary cut structure that includes the valve support 120, theradially-extending segment 150 generally extending from the first end125 of the valve support 120, and the plurality of support arms 142, 144extending from the second end 127 of the valve support 120. In otherembodiments, the frame 110 can include separately manufacturedcomponents that are coupled, linked, welded, or otherwise mechanicallyattached to one another to form the frame 110.

Referring to FIGS. 4B and 7 together, the frame 110 can be a flexiblemetal frame or support structure having a plurality of ribs and/orstruts (e.g., struts 128, 152) geometrically arranged to provide alatticework capable of being radially compressed (e.g., in a deliverystate, not shown) for delivery to a target native valve site, andcapable of radially expanding (e.g., to the radially expandedconfiguration shown in FIGS. 4A and 4B) for deployment and implantationat the target native valve site (FIGS. 5 and 6). Referring to the valvesupport 120 shown in FIGS. 4A and 4B, the ribs and struts 128 can bearranged in a plurality of geometrical patterns that can expand or flexand contract while providing sufficient resilience and strength formaintaining the integrity of the prosthetic valve component 130 housedwithin. For example, the struts 128 can be arranged in a circumferentialpattern about the longitudinal axis L_(A), wherein the circumferentialpattern includes a series of diamond, zig-zagged, sinusoidal, or othergeometric shapes.

The radially-extending segment 150 can be coupled to or extend from theupstream portion 124 of the valve support 120 (e.g., at attachmentpoints 129 a between the struts 128 as defined by a diamond-shapedgeometry of the valve support 120). Likewise, the plurality of supportarms 142, 144 can be coupled to or extend from the downstream portion126 of the valve support 120 (e.g., at attachment points 129 b onendmost peaks or crowns between adjacent struts 128 of the valve support120; FIGS. 4B and 7). Other arrangements and attachment points arecontemplated for coupling one or more of the main support arm 142 and/orsupplemental support arms 144 as well as the radially-extending segment150 to the valve support 120. In particular embodiments, and as shown inFIGS. 4B and 7, each supplemental support arm 144, such as supplementalsupport arm 148 b, can comprise an arm segment 410 of the frame 110coupled to the valve support 120 at a first attachment point 129 b ₁ anda second attachment point 129 b ₂ wherein the arm segment 410 defines aloop therebetween. In one embodiment, the arm segment 410 can beintegral with the frame 110 such that the arm segment 410 is cut orformed from a common sheet or tube as the one or more struts 128. Inanother embodiment, the arm segment 410 and valve support 120 may becoupled by a variety of methods known in the art, e.g., soldering,welding, bonding, rivets or other fasteners, mechanical interlocking, orany combination thereof.

In a similar manner, the main support arm 142 can comprise inner andouter arm segments 420, 421 configured to provide together additionalresiliency to the main support arm 142 so as to engage and trap leaflettissue between the main support arm 142 and the exterior surface 123 ofthe valve support 120 (FIGS. 4B and 7). As shown in FIGS. 4B and 7, theinner arm segment 420 can be coupled to endmost peaks or crowns of thevalve support 120 at first and second attachment points 129 b ₁, 129 b ₂in a similar manner as the arm segments 410 of the supplemental supportarms 144, thereby forming a loop therebetween. The outer arm segment 421can be coupled to attachment points 129 c ₁ and 129 c ₂ between thestruts 128 as defined by the diamond-shaped geometry of the valvesupport 120, and form a loop therebetween that generally follows theshape of the inner arm segment 420. In some embodiments, the inner andouter arm segments 420, 421 may be connected (e.g., bonded, welded orotherwise attached to one another) at any point along the length of theinner and outer arm segments 420, 421, and for example, at the tipportion 143 (as shown in FIGS. 4B and 7).

As shown in FIG. 4B, the attachment points 129 c ₁ and 129 c ₂ are setfurther apart than attachment point 129 b ₁ and 129 b ₂, thereby givingthe main support arm 142 at least a wider overall base portion 442 thanbase portions 412 of the supplemental support arms 144. Both baseportion 412 and an upper portion 414 of the supplemental support arms144 have a maximum width W₁ configured to fit between and/or minimallyinteract with chordae tendinae CT during deployment. As best seen inFIG. 4B, the maximum width W₁ of each one of the supplemental supportarms 144 is less than a width W₂ of the base portion 442 or width W₃ ofan upper portion 424 of the main support arm 142. Accordingly, the mainsupport arm 142 is configured to function as a leaflet capture arm andis sized and proportioned to capture and retain the larger A2 segment orscallop of the anterior leaflet AL, while the supplemental support arms144 are configured to reach behind the anterior and posterior leafletsAL, PL to contact and engage the dense connective tissue in thesubannular region while minimally interacting with the chordae tendinaeCT during deployment.

Referring back to FIG. 7, the plurality of support arms 142, 144 areprovided with variable lengths. For example, the main support arm 142 isprovided with a first length L₁, the first set of supplemental supportarms 146 a-d is provided with a second length L₂ less than the firstlength L₁, and the second set of supplemental support arms 148 a-c isprovided with a third length L₃ less than both the first and secondlengths L₁, L₂. In alternative arrangements, groupings of support arms142, 146, 148 can be provided with lengths greater or less than thelengths of other support arms. The variable lengths L₁, L₂ and L₃ can beprovided to accommodate the overall distances (e.g., desired heights H₂and H₃) the respective support arms 142, 146, 148 must extend tointeract with intended target cardiac tissue when deployed at the nativemitral valve. Furthermore, the lengths L₁, L₂ and L₃ can vary withrespect to each other and be selected based on the anatomy of the targettissue.

FIGS. 8A-8C are enlarged partial side views of a frame 810 for a heartvalve prosthesis in accordance with another embodiment having a mainsupport arm 842 (FIG. 8A) and various supplemental (FIGS. 8B and 8C)support arms 846, 848 coupled to and extending from a valve support 820at various reflection angles with respect to the longitudinal axis L_(A)of the valve support 820 in accordance with further embodiments of thepresent technology. As shown in FIG. 8A, a main support arm 842comprises an arm body 810 radially off-set from the valve support 120 bya curved region 812 and terminating in a curved atraumatic main arm tipor end portion 814. The arm body 810 has an arm body length L₄ and isintegral with the curved region 812 that extends the main support arm842 radially outward from the valve support 820 and in an upstreamdirection. A first reflection angle A_(R1) or taper angle is formedbetween the external wall 823 of the valve support 820 and the arm body810; the first reflection angle A_(R1) is selected such that the mainsupport arm 842 is positionable so that the arm body 810 cansufficiently engage the outward-facing anterior leaflet tissue andwherein the main arm tip 814 does not interact with the aortic leafletsor ventricular wall behind the native anterior leaflet AL. In oneembodiment, the first reflection angle A_(R1) may be approximately −10°to approximately 45°, wherein 0 degrees represents a verticaldisposition of the main support arm 842 and wherein a negative angle isin a direction toward the valve support 820 and a positive angle is in adirection away from the valve support 820. In other embodiments, thefirst reflection angle A_(R1) may be from an angle where the tip 814 ofthe main support arm 842 meets the valve support 820, or conversely maybe as great as 90° with respect to the longitudinal axis L_(A).

With reference to FIG. 8A, the arm body 810 extends from the curvedregion 812, which is located at a proximal end of the main support arm842. The curved region 812 can have an extension length L₅ which can beselected or optimized for extending the arm body 810 of the main supportarm 842 radially outward from the exterior wall 823 of the valve support820 at a sufficient distance to accommodate the anterior leaflet tissuetherebetween. The length L₄ of the arm body 810 and the length L₅ of thecurved region 812 together make up a total or cut length L₁ of the mainsupport arm 842, as similarly shown in FIG. 7 for main support arm 142.As illustrated, the valve support 820 is oriented along a centrallongitudinal axis L_(A), and the main support arm 842 can also bedescribed as flaring outward relative to the longitudinal axis L_(A) bythe reflection angle A_(R1). In embodiments where the main support arm842 generally curves outward from the curved region 812 to the arm tip814 (rather than linear), the reflection angle A_(R1) can continuouslychange along the length L₄ of the arm body 810 (see, e.g., FIG. 4A). Inthe embodiment shown in FIG. 8A, the reflection angle A_(R1) isconsistent along the length L₄ of the arm body 810.

In the expanded state shown in FIG. 8A, the main support arm 842 has amain arm height H₂ extending from the curved region 812 to thedistalmost point of the main support arm 142, which could be the arm tip814 (shown in FIG. 8A) along an axis parallel to the longitudinal axisL_(A) of the valve support 820. As discussed above, the main arm heightH₂ of the main support arm 842 in the expanded state can be selected oroptimized such that the arm tip 814 engages a desired location in thesubannular anatomy when the prosthesis is in a desired longitudinalposition relative to the native mitral valve (e.g., when thesupplemental support arms are in engagement with the subannular tissue,and when the radially-extending segment is in engagement with thesupra-annular tissue, etc.). In the expanded state, the main arm heightH₂ is a function of the cut length L₁ of the main support arm 842, thelength L₄ of the arm body 810 and the first reflection angle A_(R1) andcan be selected such that main arm height H₂ is sufficiently less thanthe overall height H₁ of the valve support 820 and to preventundesirable interrogation of subannular tissue behind the A2 segment ofthe anterior leaflet AL.

FIGS. 8B and 8C show first and second supplemental support arm 846, 848configurations in accordance with another embodiment. FIG. 8B is apartial side view of a heart valve prosthesis showing a supplementalsupport arm 846 from a first set of supplemental support arms coupled tothe valve support 820 and/or extending therefrom. The supplementalsupport arm 846 may comprise a supplemental support arm body 825 off-setfrom the valve support 820 by a curved region 822 and terminating in asupplemental support arm tip or end portion 824. The supplemental armbody 825 has an arm body length L₆ and is integral with the curvedregion 822 that extends the first supplemental support arm 846 radiallyoutward from the valve support 820 and in an upstream direction. Asecond reflection angle A_(R2) is formed between the external wall 823of the valve support 820 and the supplemental support arm body 825. Asillustrated, the first set of supplemental support arms 846 can also bedescribed as flaring outward relative to the longitudinal axis L_(A) ofthe valve support 820 by the reflection angle A_(R2). In thisembodiment, both the second reflection angle A_(R2) and the supplementalsupport arm body length L₆ are selected such that in the expanded statethe arm tips 824 of the first set of supplemental support arms 846 arepositionable to engage at least the subannular tissue or ventricularwall behind the native anterior leaflet AL at the A1 or A3 segments(e.g., proximate the anterolateral and posteromedial commissures AC,PC).

A partial side view of a heart valve prosthesis showing a supplementalsupport arm 848 of a second set of supplemental support arms coupled tothe valve support 820 and/or extending therefrom is shown in FIG. 8C.Similar to the supplemental support arm 846, the supplemental supportarm 848 comprises a supplemental support arm body 830 off-set from thevalve support 120 by a curved region 832 and terminating in a secondsupplemental support arm tip or end portion 834. The supplementalsupport arm body 830 has an arm body length L₇ and is integral with thecurved region 832 that extends the supplemental support arm 848 radiallyoutward from the valve support 820 and in an upstream direction. A thirdreflection angle A_(R3) is formed between the external wall 823 of thevalve support 820 and the supplemental support arm body 830. Asillustrated, the second set of supplemental support arms 848 can also bedescribed as flaring outward relative to the longitudinal axis L_(A) ofthe valve support 820 by the reflection angle A_(R3). In thisembodiment, both the third reflection angle A_(R3) and the supplementalsupport arm body length L₇ are selected such that in the expanded statethe arm tips 834 of the second set of supplemental support arms 848 arepositionable to engage at least the subannular tissue or ventricularwall behind the native posterior leaflet PL at the P1, P2 or P3segments.

With reference to FIGS. 8B and 8C together, in the expanded state eachof the first set of supplemental support arms 846 and each of the secondset of supplemental support arms 848 have substantially or essentiallythe same or equal supplemental support arm height H₃, as measured fromthe curved regions 822, 832, respectively, to the distalmost pointsthereof (e.g., the arm tips 824, 834, respectively) along an axisparallel to the longitudinal axis L_(A) of the valve support 820 (shownin FIGS. 8B and 8C). As discussed above with respect to FIG. 4A, thesupplemental arm height H₃ can be selected or optimized such that whenthe prosthesis is deployed the first and second supplemental support armtips 824, 834 each engage the annulus AN in a manner that provides acompressive force opposite the radially-extending segment 150 deployedabove the annulus AN to pinch the annular tissue therebetween.

The supplemental support arm height H₃ of each of the first set ofsupplemental support arms 846 shown in FIG. 8B is a function of a totalor cut length L₂ of the first set of supplemental support arms 846, assimilarly shown in FIG. 7 for supplemental support arm 146, the lengthL₆ of the arm body 820 and the second reflection angle A_(R2) and can beselected such that deployed height H₃ is less than the overall deployedheight H₁ of the valve support 820 (FIG. 8B). Likewise, the supplementalsupport arm height H₃ of each of the second set of supplemental supportarms 848 shown in FIG. 8C is a function of a total or cut length L₃ ofthe second set of supplemental support arms 848, as similarly shown inFIG. 7 for supplemental support arm 148, the length L₇ of the arm body830 and the third reflection angle A_(R3). Referring to FIGS. 8B and 8Ctogether, while the first set of supplemental support arms 846 have anoverall or cut length L₂ that is greater than the overall or cut lengthL₃ of the second set of supplemental support arms 848, and have the armbody length L₆ that is greater than the arm body length L₇ of the secondset of supplemental support arms 848, both the first and second sets ofsupplemental support arms 846, 848 have the same deployed height H₃ inan expanded or natural state because the second reflection angle A_(R2)of the first set of supplemental support arms 846 is greater than thethird reflection angle A_(R3) of the second set of supplemental supportarms 848. In embodiments hereof, the second reflection angle A_(R2)and/or the third reflection angle A_(R3) may be approximately 0° toapproximately 45°, wherein 0 degrees represents a vertical dispositionof the respective supplemental support arm and wherein a positive angleis in a direction away from the valve support 820. In other embodiments,the second reflection angle A_(R2) and/or the third reflection angleA_(R3) may be such that a tip 824, 834 of the respective supplementalsupport arm 846, 848 touches the valve support 820, or conversely may beas great as 90° with respect to the longitudinal axis L_(A). In each ofthe foregoing embodiments, the second reflection angle A_(R2) of thelonger supplemental support arm 846 is greater than the third reflectionangle A_(R3) of the shorter supplemental support arm 848. Otherreflection angles are contemplated and one of ordinary skill in the artwill recognize that supplemental support arms 144, 146, 148, 846, 848can have independently variable reflection angles whether such arms arewithin a particular set of supplemental support arms or separatelyconfigured.

In the expanded or deployed state of the prosthesis, with reference toFIGS. 8A-8C, end portions or tips 814, 824, 834 of supports arms 842,846, 848, respectively, have different radial positions relative to thevalve support 820 due to their respective arm lengths L₄, L₆, L₇ andreflection angles A_(R1), A_(R2), A_(R3). In particular, end portion 814of the main support arm 842 is a radial distance R₁ from the externalwall 823 of valve support 820, each end portion 824 of the first set ofsupplemental support arms 846 is substantially or essentially a radialdistance R₂ from the external wall 823 of valve support 820, and eachend portion 834 of the second set of supplemental support arms 848 issubstantially or essentially a radial distance R₃ from the external wall823 of valve support 820. In embodiments in accordance herewith, radialdistances R₁, R₂, and R₃ may be selected so that each of the supportarms 842, 846, 848 interacts with a desired, respective portion of thenative heart anatomy when deployed, as described herein. In embodimentsin accordance herewith, radial distance R₁ may be greater than each ofradial distances R₂, R₃. In embodiments in accordance herewith, theradial distance R₂ may be greater than the radial distance R₃.

Referring to FIGS. 3B, 4D and 8A-8C together, the heart valve prosthesis100 is configured with a plurality of support arms having the variablecharacteristics (e.g., length, arm body length and reflection angle) toprovide subannular engagement consistently about the D-shaped profile ofthe mitral valve annulus AN. For example, the further extending (e.g.,longer) first set of supplemental support arms 146, 846 provide annularengagement across the major axis of the D-shaped profile spanning fromthe anterolateral commissure AC to the posteromedial commissure PC.Likewise, the second set of supplemental support arms 148, 848 areshorter and contact the subannular tissue behind the posterior leafletPL and in a more proximal position to the valve support 120, 820 (e.g.,have a smaller reflection angle), thereby providing load bearingdistribution around the outer curved portion of the D-shaped profile ofthe annulus AN (see, e.g., FIGS. 3B and 4D). Advantageously, whileproviding more evenly distributed load bearing about the D-shapedannulus AN, the first and second supplemental support arms 146, 846,148, 848 have a narrower profile that permits minimal interaction ordisturbance of the chordae tendinae CT during and after deployment.

Referring to FIGS. 4A-6 together, several features of the prosthesis 100provide resistance to movement of the prosthesis 100, promote tissueingrowth, minimize or prevent paravalvular leakage and/or minimizenative tissue erosion when implanted in the radially expandedconfiguration. For example, the radially-extending segment 150 can bepositioned to expand within the atrial space above the mitral valve andengage cardiac tissue within the atrial space. In particular, at leastthe lower surface or apex 153 of the arching or S-shaped struts 152 thatfrom the radially-extending segment 150 can provide a tissue engagingregion for contacting the supra-annular tissue, for example to providesealing against paravalvular leakage and to inhibit downstream migrationof the prosthesis 100 relative to the native annulus (FIG. 4A).

In some embodiments, upwardly oriented portions 158 of struts 152, eachof which rises to join at a respective crown 156 an adjacent upwardlyoriented portion 158 of an adjoining or adjacent strut 152, can providefurther tissue contact zones that can further inhibit downstreammovement of the prosthesis 100 relative to the native annulus, andinhibit rocking or side-to-side rotation of the prosthesis 100 withinthe native valve during the cardiac cycle, thereby inhibitingparavalvular leakage and assuring alignment of the prosthetic valvecomponent 130 within the native annulus (FIGS. 4A and 6). In otherembodiments, the radially-extending segment 150 can be a flange, a brim,a ring, finger-like projections or other projection into the atrialspace for at least partially engaging tissue at or above a supra-annularregion thereof.

Referring to FIGS. 4A, 4B and 4D, 5 and 6 together, the plurality ofsupport arms 142, 144 are configured to engage both the native leaflets(if present) and/or the subannular region of the mitral valve MV withinthe ventricular space. In one embodiment, at least the main support arm142 is configured to engage an outside surface (e.g., ventricle-facingside) of the anterior leaflet AL such that the leaflet is capturedbetween the main support arm 142 and the exterior wall 123 of the valvesupport 120. In one such embodiment, the main support arm 142 can bebiased toward the exterior wall 123 of the valve support 120 such that acompressive force presses the anterior leaflet AL against the exteriorwall 123 in a manner that pinches, grasps, crimps or otherwise confinesthe leaflet between the main support arm 142 and the exterior wall 123of the valve support 120 (FIG. 6). To further inhibit upstream migrationof the prosthesis 100 with respect to the native valve annulus AN, thefirst and second sets of supplemental support arms 146, 148 areconfigured to engage the subannular region (e.g., behind the anteriorand posterior leaflets AL, PL, respectively) via the atraumatic tipportions 145.

In some embodiments, portions of the prosthesis 100, such as upstream,downstream and/or interior surfaces of the radially-extending segment150 and the valve support 120, and/or upstream and/or downstreamsurfaces of each of the plurality of support arms, can be fully or atleast partially covered by a sealing material 160 (FIG. 4A). In theembodiment shown in FIG. 4A, the sealing material 160 extends around atleast the downstream surface 155 of the radially-extending segment 150,around the interior wall 122 of the valve support 120, and around atleast portions of each of the plurality of support arms.

In another embodiment as best shown in FIG. 4D, a tent-like cushioningstrip 160 a of a sealing material 160, or of another material (likefoam, soft fabric, velour), may extend across and between curved regions422, 432 (see e.g., curved regions 822, 832 of supplemental support arms846, 848 in FIGS. 8B and 8C) of the supplemental support arms 146 a-dand 148 a-c to thereby providing a tent-like structure spanning theplurality of supplemental support arms. The tent-like cushioning strip160 a spanning across and between the curved regions 422, 432 of theplurality of supplemental support arms 146 a-d, 148 a-c may preventdamage to the chordae tendinae CT and/or prevent the chordae tendinae CTfrom interacting with metal portions of the supplemental support armsand the valve support 120. As shown in FIG. 4D, the cushioning strip 160a extends across upstream surfaces of the curved regions 422, 432 of theplurality of supplemental support arms 146 a-d, 148 a-c.

The sealing material 160 can prevent paravalvular leakage as well asprovide a medium for tissue ingrowth following implantation, which canfurther provide biomechanical retention of the prosthesis 100 in thedesired deployment location within the native heart valve region. Insome embodiments, the sealing material 160, the cushioning strip 160 a,or portions thereof may be a low-porosity woven fabric, such aspolyester, DACRON® polyester, or polytetrafluoroethylene (PTFE), whichcreates a one-way fluid passage when attached to the frame 110. In oneembodiment, the sealing material 160, the cushioning strip 160 a, orportions thereof may be a looser knit or woven fabric, such as apolyester or PTFE knit, which can be utilized when it is desired toprovide a medium for tissue ingrowth and the ability for the fabric tostretch to conform to a curved surface. In another embodiment, polyestervelour fabrics may alternatively be used for at least portions of thesealing material 160, the cushioning strip 160 a, or portions thereofsuch as when it is desired to provide a medium for tissue ingrowth onone side and a smooth surface on the other side. These and otherappropriate cardiovascular fabrics are commercially available from BardPeripheral Vascular, Inc. of Tempe, Ariz., for example. In anotherembodiment, the sealing material 160 or portions thereof may be anatural graft material, such as pericardium or another membranoustissue.

Selected Systems and Methods for Delivery and Implantation of ProstheticHeart Valve Devices

Several suitable delivery and deployment methods are discussed hereinand further below; however, one of ordinary skill in the art willrecognize a plurality of methods suitable to deliver the prosthesis 100to the targeted native valve region (e.g., percutaneous, transcatheterdelivery using antegrade approaches or retrograde approaches).Additionally, one of ordinary skill in the art will recognize aplurality of methods suitable to deploy the prosthesis 100 from acompressed configuration for delivery to the expanded configurationillustrated in FIG. 4A.

FIG. 9 is an enlarged sectional view of the heart valve prosthesis 100of FIGS. 4A-4D shown in a compressed delivery configuration (e.g., alow-profile or radially compressed state) and in accordance with anembodiment of the present technology. In operation, the heart valveprosthesis 100 can be intravascularly delivered to a desired nativevalve region of the heart 10, such as near the mitral valve MV, while inthe radially compressed configuration and within a delivery catheter(not shown). As shown in FIG. 9, the prosthesis 100 can be configuredfor delivery within a delivery catheter sheath 901 in the radiallycompressed state. More particularly, in the radially compressed state,the radially-extending segment 150 can be elongated, folded or otherwisearranged to longitudinally extend in a substantially straightened statefrom the inflow end 125 of the valve support 120, while the plurality ofsupport arms 142, 144 can be elongated, folded or otherwise arranged tolongitudinally extended in a substantially straightened state from theoutflow end 127 of the valve support 120 for percutaneous delivery tothe targeted native heart valve. Referring to FIG. 9, the plurality ofsupport arms 142, 148 can extend from or beyond the second end 127 ofthe valve support 120 such that the curved regions thereof (for example812, 822, 824 (FIGS. 8A-8C)) are generally linear and substantiallyparallel with the longitudinal axis L_(A). Upon release of the radialconstraint provided by the sheath 901, the radially-extending segment150 can self-expand to its radially expanded configuration (FIGS. 4A and4B) while the plurality of support arms 142, 144 can return to theircurved state (FIGS. 4A and 4B) as the delivery catheter sheath 901 iswithdrawn from covering each). Additionally, in the event that the heartvalve prosthesis 100 needs to be repositioned, removed and/or replacedafter implantation, the radially-extending segment 150 and the valvesupport 120 can transition from the radially expanded configuration(e.g., the deployed state) (FIG. 4A) back to the radially contractedconfiguration (FIG. 9) using a catheter device or other lateralretaining sheath.

Access to the mitral valve or other atrioventricular valve can beaccomplished through a patient's vasculature in a percutaneous manner.In a particular embodiment, the approach to the mitral valve isantegrade and may be accomplished via entry into the left atrium bycrossing the inter-atrial septum. In alternative arrangements, approachto the mitral valve can be retrograde where the left ventricle isentered through the aortic valve or via a transapical puncture. Oncepercutaneous access is achieved, the interventional tools and supportingcatheter(s) may be advanced to the heart intravascularly and positionedadjacent the target cardiac valve in a variety of manners. For example,the heart valve prosthesis 100 may be delivered to a native mitral valveregion for repair or replacement of the native valve via a transseptalapproach (shown in FIGS. 10A-10D). Another suitable path to the nativemitral valve may be made from the right atrium via a puncture throughthe intraventricular septum to gain access to the left ventricle.Suitable transatrial and/or transseptal implantation procedures that maybe adapted for use with the heart valve prostheses 100 described hereinare disclosed in U.S. Appl. Pub. No. 2011/0208297 to Tuval et al. andU.S. Appl. Pub. No. 2012/0035722 to Tuval et al, both of which areincorporated by reference herein in their entireties.

As is known in the art, a guidewire (not shown) may be advancedintravascularly using any number of techniques, e.g., through theinferior vena cava or superior vena cava (FIG. 1), into the right atriumRA through a penetration hole cut in the inter-atrial septum (not shown)and into the left atrium LA (FIG. 1). A guide catheter may be advancedalong the guidewire and into the right atrium RA, through thepenetration hole in the inter-atrial septum, and into the left atriumLA. The guide catheter may have a pre-shaped or steerable distal end toshape or steer the guide catheter such that it will direct a deliverycatheter (not shown) toward the mitral valve MV.

Alternatively, the mitral valve may also be accessed via a transatrialapproach for e.g., directly through an incision in the left atrium LA.Access to the heart may be obtained through an intercostal incision inthe chest without removing ribs, and a guiding catheter may be placedinto the left atrium LA through an atrial incision sealed with apurse-string suture. A delivery catheter may then be advanced throughthe guiding catheter to the mitral valve. Alternatively, the deliverycatheter may be placed directly through the atrial incision without theuse of a guiding catheter.

FIGS. 10A-10D are schematic, sectional side views of a heart showing atrans-septal or antegrade approach for delivering and deploying aprosthetic heart valve device 100 in accordance with an embodiment ofthe present technology. Referring to FIGS. 10A-10D together, a distalend 1010 of a delivery catheter 1012 may be advanced into the leftatrium LA and in general proximity to the mitral valve MV. Optionally,and as shown in FIG. 10A, a guidewire (not shown) may be used over whichthe delivery catheter 1012 may be slideably advanced. A delivery sheath1014 of the delivery catheter 1012, which contains the prosthesis 100 ina radially compressed delivery configuration (FIG. 9), is at leastpartially retracted relative to a distal nose cone 1016 allowing theplurality of support arms 142, 144 to emerge and expand radially out andreflect back toward the upstream direction (FIG. 10A). In thisdeployment phase, the outward-to-upstream movement of the plurality ofsupport arms 142, 144 from the straightened state shown in FIG. 9 to anexpanded or relaxed state shown in FIGS. 4A-4B is facilitated by theshape-memory bias of the support arms 142, 144 and such movement of oneor more of the plurality of support arms may occur in unison orconsecutively depending on where the bend in the respective support armoccurs.

Image guidance, e.g., intracardiac echocardiography (ICE), fluoroscopy,computed tomography (CT), intravascular ultrasound (IVUS), opticalcoherence tomography (OCT), or another suitable guidance modality, orcombination thereof, may be used to aid the clinician's positioning andmanipulation of the prosthesis 100 at the target native valve region.For example, once the plurality of support arms 142, 144 are deployedwithin the left atrium LA with substantially a remainder of theprosthesis 100 still compressed in a delivery configuration within thedelivery sheath 1014, such image guidance technologies can be used toaid in orienting the prosthesis 100 within the left atrium LA such thatthe main support arm 142 is aligned with the anterior leaflet, the firstset of supplemental support arms 146 are aligned with the anteriorleaflet AL at or proximate to the commissures, and the second set ofsupplemental support arms 148 are aligned with the posterior leaflet PLof the mitral valve MV. In some embodiments, image guidance components(e.g., IVUS, OCT) can be coupled to the distal portion of the deliverycatheter 1012, guide catheter, or both to provide three-dimensionalimages of the area proximate to the target heart valve region tofacilitate positioning, orienting and/or deployment of the prosthesis100 within the heart valve region.

Once the plurality of support arms 142, 144 are deployed and orientedwithin the left atrium, the delivery catheter 1012 may again be advancedtoward the mitral valve annulus AN until the plurality of support arms142, 144 are pushed through the mitral valve annulus AN between nativeanterior and posterior leaflets AL, PL, as shown in FIG. 10B. In thisdelivery step, the support arms may compress or flex toward the deliverycatheter 1012 while the delivery catheter advances through the mitralvalve annulus AN before returning back to the original shape setposition of the respective support arms (e.g., returning to its desiredreflection angle). Once the delivery catheter 1012 has advanced theplurality of support arms 142, 144 through the annulus AN and into theleft ventricle LV a suitable distance to situate the atraumatic endportions 143, 145 thereof within the left ventricle LV, the deliverycatheter 1012 can be moved or retracted proximally in a retrogradedirection such that the main support arm 142 captures the anteriorleaflet AL and the end portions 145 of the supplemental support arms 144come into contact and engage the subannular tissue.

Referring to FIG. 10C, the delivery sheath 1014 is further retractedproximally allowing the prosthesis 100 to expand such that the valvesupport 120 pushes the leaflets AL, PL outwardly to fold beneath themitral valve annulus AN and between the valve support 120 and theplurality of support arms 142, 144. The delivery sheath 1014 is fullyremoved and the radially-extending segment 150 is allowed to expandwithin the left atrium LA (FIG. 10D). During the delivery stepsillustrated in FIGS. 10C and 10D, the delivery system can maintainretraction tension so that the supplemental support arms 144 continuallymaintain engagement with the subannular tissue. After the deliverysheath 1014 has been removed and the prosthesis 100 allowed to expand,the delivery system can still be connected to the prosthesis 100 viatethers (not shown) so that the operator can further control theplacement of the prosthesis 100 as it expands toward the expandedconfiguration. Once the prosthesis 100 is positioned at the target site,the tethers (not shown) may be retracted in a proximal direction, todetach the prosthesis 100 in the deployed configuration from thedelivery catheter 1012. The delivery catheter 1012 can then be removedand the prosthesis is deployed as shown in FIG. 6. Alternatively, theprosthesis 100 may not be connected to the delivery system via tetherssuch that the prosthesis 100 deploys and is fully released from thedelivery system.

FIG. 11 is block diagram illustrating a method 1100 for repairing orreplacing a heart valve of a patient with the heart valve prosthesis 100described above with reference to FIGS. 4A-10D and in accordance with anembodiment of the present technology. Referring to FIG. 11 (and withadditional reference to FIGS. 4A-10D), the method 1100 can includeproviding transatrial access to the left atrium of the heart (block1102). The method 1100 can also include advancing a distal portion of adelivery catheter 1012 having the heart valve prosthesis 100 in thecompressed configuration therein into the left atrium LA via thetransatrial access (block 1104). The prosthesis 100 includes the frame110 having a main support arm 142 and a plurality of supplementalsupport arms 144. The method 1100 can also include deploying within theleft atrium LA the main support arm 142 and the plurality ofsupplemental support arms 144 of the prosthesis 100 (block 1106). Themain support arm 142 and each of the plurality of supplemental supportarms 144 assumes a bent and upstream extending deployed state as itextends from the distal portion of the delivery catheter 1012 duringthis step.

At block 1108, the method 1100 can further include advancing the distalportion of the delivery catheter 1012 toward the annulus AN of thenative mitral valve MV of the heart until the main support arm 142 andthe plurality of supplemental support arms 144 in the bent and upstreamextending deployed state are pushed through the annulus and into theleft ventricle of the heart. The method 1100 continues at block 1110with proximally retracting the delivery catheter until each of the mainsupport arm 142 and the plurality of supplemental support arms 144engages at least a portion of anterior and posterior leaflets AL, PL ofthe native mitral valve MV, with tips of a plurality of the supplementalsupport arms engaging the endocardial surface of the left ventricle nearthe mitral annulus. Accordingly, a primary fixation mechanism of a valveprosthesis in accordance herewith occurs between the supplementalsupport arm tips and the muscular portion of the annulus such that amitral valve prosthesis hereof is much less dependent on capturing ofthe leaflets for anchoring versus known prosthetic mitral valve designs.The method 1100 further includes deploying the remainder of theprosthesis 100 from the delivery catheter 1012 to repair or replace thenative mitral valve MV (block 1112).

Additional Embodiments

Features of the heart valve prosthesis and delivery system componentsdescribed above and illustrated in FIGS. 4A-10D can be modified to formadditional embodiments configured in accordance with the presenttechnology. For example, the heart valve prosthesis described above andillustrated in FIGS. 4A-8C showing only a single main support arm orleaflet capture arm can also include additional leaflet capture armsextending from the valve support to, for example, capture posteriorleaflet tissue and/or to further resist migration of the prosthesisfollowing implantation. Various method steps described above fordelivery and deployment of the heart valve prosthesis for repairing orreplacing a heart valve of a patient also can be interchanged to formadditional embodiments of the present technology. For example, while themethod steps described above are presented in a given order, alternativeembodiments may perform steps in a different order. The variousembodiments described herein may also be combined to provide furtherembodiments.

While various embodiments have been described above, it should beunderstood that they have been presented only as illustrations andexamples of the present technology, and not by way of limitation. Itwill be apparent to persons skilled in the relevant art that variouschanges in form and detail can be made therein without departing fromthe spirit and scope of the present technology. Thus, the breadth andscope of the present technology should not be limited by any of theabove-described embodiments, but should be defined only in accordancewith the appended claims and their equivalents. It will also beunderstood that each feature of each embodiment discussed herein, and ofeach reference cited herein, can be used in combination with thefeatures of any other embodiment. All patents and publications discussedherein are incorporated by reference herein in their entirety.

1. A valve prosthesis having a compressed delivery configuration and anexpanded deployed configuration for deployment within a heartcomprising: a frame having a tubular portion for retaining a prostheticvalve component therein, the tubular portion having a first end and asecond end; an inflow portion that radially extends from the first endof the tubular portion when the valve prosthesis is in the expandedconfiguration; a main support arm extending from the second end of thetubular portion having a first length; a first set of supplementalsupport arms extending from the second end of the tubular portion,wherein each of the first set of supplemental support arms has a secondlength; and a second set of supplemental support arms extending from thesecond end of the tubular portion, wherein each of the second set ofsupplemental support arms has a third length that is less than thesecond length, wherein the first length of the main support arm islonger than the respective second and third lengths of the supplementalsupport arms in the first and second sets of supplemental support arms.2. The valve prosthesis of claim 1, wherein the main support arm, thefirst set of supplemental support arms and the second set ofsupplemental support arms are spaced about a circumference of the secondend of the tubular portion of the frame.
 3. The valve prosthesis ofclaim 2, wherein at least one of the second set of supplemental supportarms is positioned to be diametrically opposed with the main supportarm.
 4. The valve prosthesis of claim 3, wherein one of the first set ofsupplemental support arms is circumferentially positioned on each sideof the main support arm.
 5. The valve prosthesis of claim 1, wherein inthe expanded configuration the main support arm, the first set ofsupplemental support arms and the second set of supplemental supportarms bend toward the first end of the tubular portion of the frame. 6.The valve prosthesis of claim 5, wherein in the expanded configurationeach end portion of the supplemental support arms of the first andsecond sets of supplemental support arms are disposed at substantiallythe same longitudinal position or height relative to the tubular portionof the frame.
 7. The valve prosthesis of claim 6, wherein in theexpanded configuration each end portion of the supplemental support armsof the first and second sets of supplemental support arms contacts theinflow portion for pinching tissue of the heart therebetween.
 8. Thevalve prosthesis of claim 5, wherein in the expanded configuration afirst angle is defined between the main support arm and the tubularportion of the frame; a second angle is defined between eachsupplemental support arm of the first set of supplemental support armsand the tubular portion of the frame; and a third angle is definedbetween each supplemental support arm of the second set of supplementalsupport arms and the tubular portion of the frame, wherein the first,second and third angles are not equal.
 9. The valve prosthesis of claim8, wherein the first angle is greater than the second angle and thesecond angle is greater than the third angle.
 10. The valve prosthesisof claim 1, further comprising: a prosthetic valve secured within thetubular portion of the frame; and sealing material secured to the frameto cover one or more of portions of the tubular portion, the inflowportion, and at least an end portion of the main support arm and an endportion of each of the supplemental support arms of the first and secondsets of supplemental support arms.
 11. The valve prosthesis of claim 10,further comprising: a cushioning strip disposed around a portion of aperimeter of the second end of the frame to cover and extend betweencurved portions of each of the supplemental support arms of the firstand second sets of supplemental support arms when the valve prosthesisis in the expanded configuration
 12. A valve prosthesis having acompressed delivery configuration and an expanded deployed configurationfor deployment within a heart comprising: a frame having a valve supportwith a first end and a second end; an inflow portion that radiallyextends from the first end of the valve support when the valveprosthesis is in the expanded configuration; a main support armextending from the second end of the valve support; a plurality of tallsupplemental support arms extending from the second end of the valvesupport; and a plurality of short supplemental support arms extendingfrom the second end of the valve support, wherein the main support armis longer than the pluralities of tall and short supplemental supportarms, and wherein in the expanded configuration the main support arm,the plurality of tall supplemental support arms and the plurality ofshort supplemental support arms bend toward the first end of the valvesupport, and wherein in the expanded configuration each of the pluralityof tall supplemental support arms and each of the plurality of shortsupplemental support arms has substantially the same deployed height.13. The valve prosthesis of claim 12, wherein in the expandedconfiguration end portions of the tall and short supplemental supportarms contact the inflow portion for pinching annular tissue of the hearttherebetween when deployed.
 14. The valve prosthesis of claim 12,wherein the main support arm and the pluralities of tall and shortsupplemental support arms are spaced about a circumference of the secondend of the valve support.
 15. The valve prosthesis of claim 14, whereinthe main support arm and the plurality of tall supplemental support armsare disposed about the circumference of the second end to engage ananterior leaflet of a native mitral valve when the valve prosthesis isin the expanded configuration within a heart, and wherein the pluralityof short supplemental support arms are disposed about the circumferenceof the second end to engage a posterior leaflet of a native mitral valvewhen the valve prosthesis is in the expanded configuration within aheart.
 16. A method of deploying a valve prosthesis having a compressedconfiguration for delivery to a treatment site and an expandedconfiguration for deployment within a heart comprising: providingtransatrial access to a left atrium of the heart; advancing a distalportion of a delivery catheter having the valve prosthesis in thecompressed configuration therein into the left atrium via thetransatrial access, wherein the valve prosthesis includes a frame havinga main support arm and a plurality of supplemental support arms;deploying within the left atrium the main support arm and the pluralityof supplemental support arms of the valve prosthesis such that the mainsupport arm and each of the plurality of supplemental support armsassumes a bent deployed state as it extends from the distal portion ofthe delivery catheter; advancing the distal portion of the deliverycatheter toward an annulus of a native mitral valve of the heart untilthe main support arm and the plurality of supplemental support arms inthe bent deployed state are pushed through the annulus and into a leftventricle of the heart; proximally retracting the delivery catheteruntil each of the main support arm and the plurality of supplementalsupport arms engages at least a portion of anterior and posteriorleaflets of the native mitral valve; and deploying a remainder of thevalve prosthesis from the delivery catheter to replace the native mitralvalve.
 17. The method of claim 16, further comprising: orienting themain support arm of the valve prosthesis with an A2 segment of theanterior leaflet of the native mitral valve prior to performing the stepof advancing the distal portion of the delivery catheter toward anannulus of the native mitral valve.
 18. The method of claim 17, whereinduring the step of proximally retracting the delivery catheter the mainsupport arm of the valve prosthesis is configured to engage and capturethe anterior leaflet at the A2 segment prior to the plurality ofsupplemental support arms engaging remaining segments of the anteriorleaflet and segments of the posterior leaflet.
 19. The method of claim16, wherein during the step of proximally retracting the deliverycatheter end portions of the plurality of supplemental support arms areforced against the annulus and the force is maintained against theannulus while the step of deploying a remainder of the valve prosthesisis performed.
 20. The method of claim 19, wherein the step of deployinga remainder of the valve prosthesis includes releasing within the leftatrium an inlet section of the frame of the valve prosthesis to actagainst a floor of the left atrium in opposition to the plurality ofsupplemental support arms that act against an inferior side of theannulus to thereby anchor the valve prosthesis within the native mitralvalve.